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May 28 — Genetically engineered organisms increasingly are being developed in ways that leave them outside of federal oversight, and synthetic biology will accelerate this trends, according to a report released May 28 by the J. Craig Venter Institute.

The institute's report examines regulatory gaps in federal oversight over plants and organisms engineered with synthetic biology and options to address those gaps.

A separate report on research needed to address ecological risks of varied applications of synthetic biology will be released May 29 by the Woodrow Wilson Center's Synthetic Biology Project and the Massachusetts Institute of Technology.

Synthetic biology involves making DNA from scratch (rather than obtaining it from living organisms) and combining it to form genes or other biological systems designed to carry out specific tasks such as producing biofuels or secreting precursors of medical drugs, according to the Wilson Center's website.

By 2020, the global market for products made with synthetic biology is projected to be in the billion of dollars, according to market intelligence firms.

Transparency Market Research, for instance, predicted two years ago that the global market would reach $16.7 billion by 2018.

However, on May 27, Allied Market Research released its Global Synthetic Biology Market forecast and projected the market would reach $38.7 billion by 2020.

Regulatory Gaps, Options

In its report, “Synthetic Biology and the U.S. Biotechnology Regulatory System: Challenges and Options,” the Venter Institute examined the authorities provided the three agencies with principal regulatory responsibility for plants and organisms engineered with synthetic biology. It then looks at regulatory gaps and options to address them.

The agencies are the U.S. Agriculture Department's Animal and Plant Health Inspection Service (APHIS), the Environmental Protection Agency and the Food and Drug Administration.

The report identifies two key gaps in federal oversight:

APHIS has authority to review genetically engineered organisms but is limited to plants made with older genetic engineering techniques and has no authority over organisms engineered using several newer techniques.

The EPA may not have the funding and expertise to adequately and promptly review the larger number and more diverse set of genetically engineered microbes it is likely to have to examine in the coming years.

The Venter Institute, which conducts genomic research and analyzes policy implications, didn't offer policy recommendations in its report.

Instead, the report provided multiple options to address these problems.

The options discused include focusing the authority of APHIS and the EPA on plants and organisms more likely to pose higher risks or expanding the agencies' authorities, which would require congressional action.

Research Challenges

The Venter Institute report also identified additional challenges. For example, universities may find it difficult to undertake some federally funded research because there will be no federal agency with jurisdiction over the field or environmental trials needed.

The Venter report said that guidelines established by the National Institutes of Health preclude federally funded scientists from releasing genetically engineered plants or organisms into non-contained environments unless the release is done under the approval process of the relevant federal regulatory agency.

If no agency has jurisdiction, university researchers cannot grow the engineered plants in the field without violating the NIH guidelines, thus jeopardizing future federal funding, the report said.

It is unclear whether NIH's guidelines would jeopardize some of the research the Woodrow Wilson Center and MIT recommended in their report, “Creating a Research Agenda for the Ecological Implications of Synthetic Biology,” Todd Kuiken, a senior program associate at the Woodrow Wilson Center and coauthor of the report, told Bloomberg BNA May 28.

General Issues Identified

The Venter Institute's report is useful because it identifies general issues in genetic research that will need to be worked out as the number of applications of synthetic biology increases, he said.

The Woodrow Wilson Center/MIT report urged government agencies, academia and industry to develop a prioritized research strategy.

Multidisciplinary research teams that include synthetic biologists, evolutionary biologists, ecologists, environmental scientists, social scientists, and others should then be funded to undertake that research, the report said.

The recommendations in the report resulted from workshops the Wilson Center and MIT held to examine case studies involving current and emerging applications of synthetic biology with environmental implications.

Case Studies

The case studies included:

re-engineering crops with synthetic DNA to minimize the amount of fertilizer needed;

altering genes needed for reproduction to control invasive animal species or to reduce vector-borne diseases and

re-engineering microbes to increase the solubility of copper to capture a greater portion of the metal from mining operations.

To contact the reporter on this story: Pat Rizzuto in Washington at prizzuto@bna.com

To contact the editor responsible for this story: Larry Pearl at lpearl@bna.com

“Synthetic Biology and the U.S. Biotechnology Regulatory System: Challenges and Options” is available at http://tinyurl.com/nkjp7pr.

“Creating a Research Agenda for the Ecological Implications of Synthetic Biology” and related information will be available at http://www.synbioproject.org/.

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